PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals
FDA device recall Z-1403-2013 · posted 2013-05-25 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
- Action taken
- Polymer Technology Systems sent a Field Correction Action letters dated April 4, 2013 to distributors and customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use and dispose of remaining inventory of recalled product. Customers were asked to acknowledge and confirm recall directions were follwed by fax to 1-317-870-5608.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 7048 total, 3499 in USA
- Distribution
- Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
- Date initiated
- 2013-04-04
- Date posted
- 2013-05-25
- Date terminated
- 2014-04-16
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSCANNER 2000 (K013068) | Polymer Technology Systems, Inc. | 2001-11-20 |